Childhood Adenotonsillectomy Study for Children With OSAS

Because adenotonsillectomy is the usual treatment for OSAS, all children in the study will
get surgery. However, in order to assess the extent to which adenotonsillectomy surgery
improves breathing disturbances and sleep quality in children with OSAS, two groups will be
studied. One group will get surgery early (one month after enrollment) and the other group
will be re-evaluated for surgery within 7 months of enrollment.

Children in both groups will be closely monitored through the 7-8 month study period and
sleep and health educational materials will be provided to assist in establishing healthy
habits.

Inclusion Criteria:

1. Ages 5.0 to 9.99 years at time of screening.

2. Diagnosed with Obstructive Sleep Apnea defined as: Obstructive Apnea Index (OAI) ≥ 1
or Apnea Hypopnea Index (AHI) ≥ 2, confirmed on nocturnal, laboratory-based PSG and
Parental report of habitual snoring (on average occurring >3 nights per week).

3. Tonsillar hypertrophy ≥ 1 based on a standardized scale of 0-4: 0 = surgically
absent, 1 = taking up < 25% of the airway, 2 = 25 - 50 % of the airway,3 = 50 - 75 %
of the airway, 4 = > 75% of the airway

4. Deemed to be a surgical candidate for AT by Ear, Nose and Throat specialist (ENT)
evaluation.

Exclusion Criteria:

1. Recurrent tonsillitis defined as: >3 episodes in each of 3 years, 5 episodes in each
of 2 years, or 7 episodes in one year

2. Craniofacial anomalies, including cleft lip and palate or sub-mucosal cleft palate or
any anatomic or systemic condition which would interfere with general anesthesia or
removal of tonsils and adenoid tissue in the standard fashion

3. Obstructive breathing while awake that merits prompt AT in the opinion of the child's
physician

4. Severe OSAS or significant hypoxemia requiring immediate AT as defined by: OAI>20 or
AHI>30, desaturation defined as oxygen saturation (SaO2) <90% for more than 2% sleep
time

5. Apnea hypopnea indices in the normal range (OAI < 1 and AHI <2)

6. Evidence of clinically significant cardiac arrhythmia on PSG: Non-sustained
ventricular tachycardia Atrial fibrillation, Second degree atrioventricular (AV)
block: Sustained bradycardia < 40 bpm (> 2 minutes, Sustained tachycardia > 140 bpm
(> 2 minutes)

7. Extremely overweight defined as: body mass index > 2.99 age group and sex-z-score

8. Severe health problems that could be exacerbated by delayed treatment for OSAS
Including: Doctor-diagnosed heart disease or cor pulmonale, history of Stage II
Hypertension (HTN) defined as > 99% percentile plus 5 mmHg for either systolic or
diastolic, based on the age, gender, and height and/or requiring medication, therapy
for failure to thrive or short stature, psychiatric or behavioral disorders requiring
or likely to require initiation of new medication, therapy, or other specific
treatment. School aged children, parental report of excessive daytime sleepiness
defined as unable to maintain wakefulness, at least three times per week, in routine
activities in school or home, despite adequate opportunity to sleep.

9. Severe chronic health conditions that might hamper participation including: severe
cardiopulmonary disorders, sickle cell anemia, poorly controlled asthma, epilepsy
requiring medication, diabetes (type I or type II) requiring medication, conditions
likely to preclude accurate polysomnography (e.g. severe uncontrolled pain),mental
retardation or enrollment in a formal school Individual Educational Plan (IEP) and
assigned to a self-contained classroom for all academic subjects, history of
inability to complete cognitive testing and/or score on the Differential Ability
Scale (DAS) II of ≤ 55, chronic infection or HIV

10. Known genetic, craniofacial, neurological or psychiatric conditions likely to affect
the airway, cognition, or behavior

11. Current use of one or more of the following medications: psychotropics,
hypnotics,hypoglycemic agents or insulin,antihypertensives,growth hormone,
anticonvulsants,anti-coagulants,daily oral corticosteroids, daily medications for
pain

12. Previous upper airway surgery on the nose, pharynx or larynx, including
tonsillectomy. Ear surgery and/or pressure equalizing (PE) tubes are not exclusion
criteria

13. Receives Continuous Positive Airway Pressure (CPAP) treatment

14. A parent or guardian who cannot accompany the child on the night of polysomnogram
(PSG)

15. A family planning to move out of the area within the year

16. Female participants only: Parental report that child has reached menarche